TGA: Manufacturing principles for medicinal products

The Therapeutic Goods (Manufacturing Principles) Determination No 1 (2013)(link is external) specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP) - 15 January 2009, PE 009-8, except for its Annexes 4, 5 and 14 which are not adopted by Australia. Through the operation of section 36 and other provisions within the Act, the PIC/S Guide to GMP has legal force in Australia.

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National Codes and Guidelines

Office of the Gene Technology Regulator (AU). Guidelines and forms for certifications of physical containment facilities

Under the Gene Technology Act 2000 (the Act), the Gene Technology Regulator (the Regulator) may issue technical and procedural guidelines in relation to genetically modified organisms (GMOs) (under section 27 of the Act), in relation to certification of facilities to specified containment levels (section 90) and in relation to accreditation of organisations (section 98). The Act, the Gene Technology Regulations 2001 or instruments issued by the Regulator can require compliance with these guidelines in conducting dealings with GMOs or in obtaining and maintaining certification or accreditation.

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National Codes and Guidelines

National Association of Testing Authorities (NATA): General Equipment - Calibration and Checks

For NATA’s policies on metrological traceability and equipment please refer to NATA Policy 11 Policy on Metrological Traceability and Policy Circular 12 NATA Policy on equipment assurance, in-house calibration and equipment verification. The recommended calibration and checking intervals as presented in this table is to be used in conjunction with the guidance on establishing an equipment assurance program as found in the informative annex of Policy Circular 12.

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National Codes and Guidelines

NHMRC: Genetics in Family Medicine: The Australian Handbook for General Practitioners

In late 2004, The Australian Government agency Biotechnology Australia initiated a project to develop a national educational resource on genetic medicine for Australian GPs. The outcome of this project is the Genetics in Family Medicine: The Australian Handbook for General Practitioners, published in 2007. It includes a range of short factsheets on each topic for patients and their families, which are available for download below. In May 2015 responsibility for the Genetics in Family Medicine: The Australian Handbook for General Practitioners resource was transferred to The Royal Australian College of General Practitioners (RACGP).

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National Codes and Guidelines

NHMRC: Genetic discrimination

Discrimination against an individual can appear in many forms. As DNA testing increasingly identifies differences in the genetic make-up of individuals, it becomes possible that people will be discriminated against based on genetic information. This resource has been developed to provide information to consumers about genetic discrimination.

The Commission has released this issues paper to assist individuals and organisations to prepare submissions to the inquiry. It contains and outlines: • the scope of the inquiry • the Commission’s procedures • matters about which the Commission is seeking comment and information • how to make a submission.

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National Codes and Guidelines

Population Health Research Network (PHRN): Privacy

The primary objective of the PHRN and its Data Linkage Units is to provide approved access to reliable health and health related information for research projects that will benefit the Australian community and are conducted in a way that maximises the protection of people's privacy.

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National Codes and Guidelines

Australian Data Linkage Units

The Population Health Research Network (PHRN) collaboration has involves six state/territory data linkage units in Western Australia, New South Wales, South Australia/Northern Territory, Tasmania, Queensland and Victoria and a National Data Linkage Unit at the Australian Institute of Health and Welfare.

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National Codes and Guidelines

Privacy business resource 4: De-identification of data and information

De-identification of personal information can enable information to be shared or published without jeopardising personal privacy. This enables organisations to maximise the utility and value of information assets while safeguarding privacy and confidentiality.

A National minimum data set (NMDS) is a minimum set of data elements agreed for mandatory collection and reporting at a national level. It may include data elements that are also included in other NMDSs. An NMDS is contingent upon a national agreement to collect uniform data and to supply it as part of the national collection, but does not preclude agencies and service providers from collecting additional data to meet their own specific needs.